Public Awareness

Frequently Asked Questions

Choosing to participate in a research is a very important
decision. The following information is written with the aim to help you
understand the issues surrounding research and perhaps relieve some
concerns relating to participating in research. It is often helpful to
talk to a doctor, family members, or friends about deciding to join a
research study.

1. What is clinical
research?Research is conducted in human volunteers
to answer specific health questions. Some other words that describe
research are clinical trial, protocol, survey or experiment. Research is
not the same as treatment.

2. Why is research
important?Biomedical research is essential for
searching for better, faster and cheaper alternatives to existing
treatment and diagnostic options. Research has led to important
discoveries that make our lives better. Some examples are- New
drugs to treat diseases such as cancer- Diagnostics tests, x
ray machines, MRI scanners- Vaccines- Ways to lose
weight

3. Why do people participate in a research
study?There are various reasons why people
volunteer to be a research participant. The usual reasons why people
participate in a research study are that they feel they are able to play
a more active role in their own health care, gain access to new
research treatments before they are widely available.

Many people participate in research for an altruistic reason -
to help increase medical knowledge that will help future
patients.

4. Who can participate in a research
study?Each research study has specific criteria
about who can participate. The factors that allow someone to participate
in a research are called "inclusion criteria" and those that disallow
someone from participating are called "exclusion criteria". These
criteria are based on such factors as age, gender, the type and stage of
a disease, previous treatment history, and other medical
conditions.

The inclusion and exclusion criteria are used to identify
appropriate participants and keep them safe. The criteria help ensure
that researchers will be able to answer the questions they plan to
study. Before joining a research, a participant is screened using these
criteria to see whether he or she qualifies for participation in the
study.

5. What happens during a research
study?The research team, which may include doctors,
nurses and other health care professionals, will check the health of the
participant at the beginning of the research study and screen the
participant using specific inclusion / exclusion criteria. A participant
who is found to be eligible will be enrolled into the research study
and the research team performs the research related activities according
to the research protocol. The research participants might have more
tests and doctor visits than patients who are not participating in the
research.

6. Is it safe to participate in a research
study?Many people fear that participating in
medical research will result in them taking drugs of unknown dosage or
undergo some unproven dangerous treatments. Some may have concerns where
and how the research results may be used or who will gain access to the
results.

The ethical and legal codes that govern medical practice also
apply to research. In addition, there are numerous regulations and
guidelines that define safeguards to protect the participants.

NHG has a robust Human Subjects Protection Program to protect
the safety and well being of research participants. All research studies
conducted in NHG are reviewed by an independent ethics committee called
the Domain Specific Review Boards (DSRB). Only the research that is
approved by the DSRB can be conducted in NHG. The DSRB is composed of
medical doctors, paramedical staff, statisticians, and lay people who
collectively review all research proposals to ensure that the research
is ethical and the rights, safety and welfare of research participants
are protected.

7. What is informed
consent?Informed consent is the process in which the
researcher provides adequate information to a potential participant to
assist in making an informed decision on whether or not to participate
in the study. This information includes details about the study, such as
its purpose, duration, required procedures, potential risks and
potential benefits. The participant is provided with a Participant
Information Sheet with all these details. The participant is given the
time to think carefully about the study and the opportunity to ask
questions before making a decision.

Informed consent is not a binding contract, and the participant
may withdraw from participating in the research at any time.

8. What should you
consider before participating in the research?If
you are interested in participating in a research study, you must try to
find out as much as possible about the study. Most of this information
can be found in the Participant Information Sheet for the study. For
example you may ask about the following:

Study Details
- - What is the purpose
of the research
study? - What
procedures will be followed in this
study? - What are your
responsibilities in this study?

Medical care
- - What is not
standard care or experimental in this
study? - Who will be in
charge of your care? -
Would you be able to continue to see your own
doctor? - Who to
contact if you have adverse events?

Possible Risks and
Benefits - What are the
possible risks and side
effects? - What are the
possible benefits from participating in the
study? - Would it be
necessary to practice contraception during the study
period? - What are the
alternatives to participation?

Costs and
Compensation - What are
the costs & extra payments if you participate in the
study? - Could you stop
participating if you change your
mind? - Would there be
compensation for research related injury?

Other
issues - What are the
measures in place to protect confidentiality of your medical
information? - What are
the measures in place to protect confidentiality of your medical
information? - Would
you have access to the study treatment after the completion of the
study? - Who is
conducting the research study?

9. What are
the responsibilities of participating in a
study?Research participants should follow the advice
given by the study team. Participants should be prepared to visit the
hospital and undergo all the procedures that are outlined in the consent
form.

10. What are the benefits of
participating in a study?A research study that is
well-designed and well-executed enables the participant to play an
active role in their own health care, gain access to new research
treatments before they are widely available and help others by
contributing to medical research.

11. What are the risks of
participating in a research study?New drugs or
procedures may have side effects that are unknown. New drugs or
procedures might be less effective than currently available treatment.
Even if a new drug has benefits, it might not work for you. The
questions being asked as a part of the research might make you feel
uncomfortable.

12. What is
randomization?In some research studies, participants
are randomised (equivalent to "tossing of coin") into treatment groups.
In some of these studies, neither the participant nor the researchers
may know what treatment they would receive during the research
study.

13. What happens if I suffer an adverse
event or an emergency while participating in a research
study?Should you experience any adverse reaction or
has an emergency during a study; you should inform the treating doctor
and contact the researchers immediately.

14. What are the various types of
research?There are many unanswered questions in
healthcare. Research studies are designed to answer some of these
questions. The research design varies with the research question being
asked. Some of the more common types of research are:

-

Interventional research
is designed to determine whether a new treatment, new combination of
drugs, a new device, a new surgical intervention, or new radiation
therapy is safe and effective.

-

Prevention research is
designed to look for better ways to prevent disease. These include
research on drugs, vitamins, vaccines, minerals, and lifestyle
changes.

-

Diagnostic research
studies are conducted to find better tests or procedures for diagnosing a
particular disease or condition.

-

Screening research study test the
best way to detect certain diseases or health
conditions.

-

Epidemiological research try to
answer health issues in large groups of people or populations in natural
settings.

-

Quality of Life research explores
ways to improve comfort and the quality of life for individuals with a
chronic
illness.

15. What are the phases of a Clinical
Trial?The process of development of a new drug
involves various phases. Before a drug is study in humans it undergoes
extensive pre-clinical testing. Here is simple description of the four
phases of a clinical trial:

-

Phase I :This first phase
is carried out to assess the safety of the new drug. Only small groups
of volunteers (20-80) are recruited for this
phase.

-

Phase II :Once a drug is
shown to be safe in Phase I testing, it goes on to phase II trials to
test the efficacy. In Phase II, a larger group (100-300) of patients
with the disease is involved.

-

Phase III :During this
phase, the drug efficacy is determined and larger group of population
(1,000-3,000) is recruited. Results from phase III helps pharmaceutical
drugs gain further knowledge on the drug's effectiveness, benefits and
range of possible adverse reactions.

-

Phase IV :This phase is
also known as the post marketing phase. Phase IV clinical aim to
determine how a particular drug compares to other currently available
drugs especially with regards to long term safety, efficacy and cost
effectiveness.

16. Who sponsors
research?Research are sponsored or funded by various
bodies such as hospitals, foundations, voluntary groups, and
pharmaceutical companies, in addition to government agencies such as the
A* Star and National Medical Research Council.

For a brief overview on clinical research, clinical research
participation and useful contact information, please download the Research Participant
Brochure.